Medicine guide

Severe Cold and Flu

325 mg/15mL + 10 mg/15mL + 6.25 mg/15mL + 5 mg/15mL · Solution

Available without prescription
Antihistamine

Active substance: Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Used in: Breathing, airways, allergies and cough
Made by: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-01-26

What it is

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Used for

Nasal congestion
Sinus congestion and pressure
Cough due to minor throat and bronchial irritation
Cough to help you sleep
Minor aches and pains

+7 more

How to take it

Adults & children 12 yrs & over 30 mL every 4 hrs

Full directions ↓

Do not take it if

With any other drug containing acetaminophen (prescription or nonprescription).

All warnings ↓

Good to know

Sold without a prescription
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

42other products contain Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

temporarily relieves common cold/flu symptoms:

nasal congestion
sinus congestion and pressure
cough due to minor throat and bronchial irritation
cough to help you sleep
minor aches and pains
headache
fever
sore throat
runny nose and sneezing
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage

From the official label · 2026-01-26 · DailyMed

Do not take it if

with any other drug containing acetaminophen (prescription or nonprescription).
If you are not sure whether a drug contains acetaminophen,
ask a doctor or pharmacist.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.
If you do not know if your prescription drug contains an MAOI,
ask a doctor or pharmacist before taking this product.
to make a child sleepy
if you have ever had an allergic reaction to this product or any of its ingredients

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

take only as directed – see Overdose warning
only use the dose cup provided
do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over 30 mL every 4 hrs
children 6 to under 12 yrs 15 mL every 4 hrs
children 4 to under 6 yrs
ask a doctor
children under 4 yrs
do not use

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first if

liver disease
heart disease
glaucoma
thyroid disease
diabetes
high blood pressure
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first if

you are
taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help if

you get nervous, dizzy or sleepless
pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

Quoted from the official label, section “OTC — Stop Use”.

Other warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if
adult takes more than 4,000 mg of acetaminophen in 24 hours
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
skin reddening
blisters
rash If a skin reaction occurs,
stop use and seek medical help right away. Sore throat warning:
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
Ask a doctor before use
if you have
glaucoma
diabetes
Ask a doctor or pharmacist before use
if you are
taking sedatives or tranquilizers When using this product
do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and
ask a doctor if
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. Overdose warning:
do not use more than directed
excitability may occur, especially in children
marked drowsiness may occur
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Keep away from children

Overdose warning:
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for
adults as well as for children even
if you do not notice any signs or symptoms.

Quoted from the official label, section “OTC — Keep Out of Reach of Children”.

Other information

each 15 mL contains: sodium 15 mg
store at 20-25°C (68-77°F)

Quoted from the official label, section “OTC — Other Information”.

What kind of medicine it is

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

1-800-719-9260

Quoted from the official label, section “OTC — Questions”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Colour dyesD&C yellow #10; FD&C green #3; FD&C red #40; FD&C yellow #6Some people react to dyes such as tartrazine (Yellow 5) or carmine.
Sugar alcoholssorbitol solutionSorbitol and similar can upset the stomach and matter with fructose intolerance.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (13)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 13 of 13

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (6)

Details

Made by	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Active substance	Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Used in	Breathing, airways, allergies and cough
Strength	325 mg/15mL + 10 mg/15mL + 6.25 mg/15mL + 5 mg/15mL
Form	Solution
Route	Oral
Packs	355 mL in 1 BOTTLE
NDC	51316-533

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

11 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Solution7 products
- 325 mg/15mL + 10 mg/15mL + 6.25 mg/15mL + 5 mg/15mL2
  325 mg/15mL + 10 mg/15mL + 6.25 mg/15mL + 5 mg/15mL · 2 companies
  - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · this page
  - HyVee Inc
- 325 mg/15mL + 10 mg/15mL + 200 mg/15mL + 5 mg/15mL3
  325 mg/15mL + 10 mg/15mL + 200 mg/15mL + 5 mg/15mL · 3 companies
- 650 mg/30mL + 20 mg/30mL + 12.5 mg/30mL + 10 mg/30mL2
  650 mg/30mL + 20 mg/30mL + 12.5 mg/30mL + 10 mg/30mL · 2 companies
  - HyVee Inc
  - Walgreen Company
Tablet, Film Coated2 products
- 325 mg + 10 mg + 200 mg + 5 mg2
  325 mg + 10 mg + 200 mg + 5 mg · 2 companies
  - Cardinal Health 110, LLC. DBA Leader
  - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Kit1 products
- —
Tablet, Coated1 products
- 325 mg + 10 mg + 200 mg + 5 mg

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Alka Seltzer Cold Cold Flu and Congestion Severe Night Fast Gels5 mg + 325 mg + 10 mg + 6.25 mgWithout prescriptionCapsule, Liquid Filled Bayer HealthCare LLC. · Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride Alka-Seltzer Plus Maximum Strength Night Cold and Flu10 mg + 325 mg + 6.25 mg + 5 mgWithout prescriptionCapsule, Liquid Filled Bayer HealthCare LLC. · Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride Alka-Seltzer Plus Maximum Strength Night Cold and Flu Powermax Gels5 mg + 325 mg + 10 mg + 6.25 mgWithout prescriptionCapsule, Liquid Filled Bayer HealthCare LLC. · Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightWithout prescriptionKit Bayer HealthCare LLC. · Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough325 mg + 10 mg + 6.25 mg + 5 mgWithout prescriptionCapsule, Liquid Filled Bayer HealthCare LLC. · Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride Asp Nighttime Max325 mg + 10 mg + 6.25 mg + 5 mgWithout prescriptionCapsule, Liquid Filled Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. · Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride

See every product with Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride